Regulatory Affairs - New Drug Development, Senior Specialist

3+ years

Not Disclosed

Tokyo

10 Oct. 16, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Lead (Japan)

The Position:

Join our Regional Regulatory Affairs and Affiliate Pharmacovigilance (RAaPV) organization, reporting directly to the Head of Japan Regulatory Affairs. You will play a pivotal role in shaping regulatory strategies for new drugs throughout their lifecycle.

Responsibilities:

Primary Activities:

Develop comprehensive regulatory strategies for new drugs in Japan, covering early phases through Lifecycle Management (LCM) activities, including new indications, line extensions, and major efficacy variations.
Collaborate with commercial teams and local stakeholders to align regional regulatory strategies with national priorities.
Facilitate communication with country teams to develop effective local regulatory strategies, identifying optimal regulatory options for filings and pre-submission support.
Serve as the primary liaison with Regulatory Franchise and Global Product Strategy teams on key strategic issues, ensuring timely updates on guidelines and requirements for Japan and regional countries.
Act as the main point of contact for local Health Authorities (PMDA).
Oversee external service providers to ensure compliance and efficiency.

This position requires strong communication and teamwork skills to effectively collaborate with local and global functions.

Additional Responsibilities:

Serve as a Subject Matter Expert (SME) for regulatory affairs-related systems and procedures as needed.
Handle inquiries and communications from local Health Authorities and hospitals regarding regulatory affairs.
Work collaboratively within matrix environments, engaging with global teams.

Required Education, Experience, and Skills:

Bachelor’s degree with a minimum of 15 years in the pharmaceutical industry, including at least 3 years of relevant experience, OR
Master’s degree with at least 10 years in the pharmaceutical industry, including 3 years of directly related experience.
In-depth knowledge of regulations pertaining to new drug registration and risk/safety standards is essential.
Proven leadership in new drug strategy, with strong communication, decision-making, and problem-solving skills.
Proficiency in Japanese (native level) and English (business level).

About Us:

At Organon, we are committed to delivering innovative health solutions that empower individuals to lead healthier lives. As a $6.5 billion global healthcare company, our focus on Women's Health drives us to invest in unmet needs and expand access to essential treatments.

We are an equal opportunity employer, welcoming applications from diverse backgrounds and committed to fostering an inclusive work environment.

For accommodations during the application process, please contact us at staffingaadar@organon.com.

Search Firm Representatives: Please note that unsolicited assistance from search firms will not be accepted. All submissions without a valid agreement will be considered the sole property of Organon.

Travel Requirements: Employees must meet all applicable travel and credentialing requirements.

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Regulatory Affairs - New Drug Development, Senior Specialist

Job Description

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